Percutaneous clip for repairing a heart valve

ABSTRACT

Valve repair systems and clips for attachment to one or more leaflets of a heart valve. The clip can include an elongated member configured to be positioned between two leaflets of the heart valve. The elongated member can have a first portion and a second portion that extends from the first portion. A width of the second portion can be greater than the width of the first portion. A pair of arms can be coupled to the first portion and extend toward the second portion. The pair of arms can extend radially away from the elongated member as the pair of arms extend away from the first portion toward the second portion when the arms are in an open position. And the pair of arms can be moveable from the open position to a closed position to pinch each leaflet between one of the arms and the elongated member.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/959,903, filed Dec. 4, 2015, which claims the benefit of U.S.Provisional Patent Application No. 62/087,530, filed Dec. 4, 2014, eachof which is hereby incorporated herein by reference in its entirety forall purposes.

FIELD

This disclosure relates to devices and methods of treating heart valveinsufficiency.

BACKGROUND

Heart valve insufficiency typically involves regurgitation of bloodthrough a heart valve that is unable to close completely or properly,resulting in impaired cardiovascular function. Valvular insufficiencymay affect, for example, the mitral valve, the aortic valve, or thetricuspid valve, and can be associated with calcified or prolapsedleaflets, and/or expansion or deformation of the valve annulus. Onemethod of treating heart valve insufficiency is to employ one or moreleaflet clips to improve coaptation of the native valve leaflets.However, conventional leaflet clips can be difficult to implant, caninterfere with the function of or damage associated valve structuressuch as chordae, and are frequently limited to use with a single type ofheart valve. Accordingly, improvements to devices and methods oftreating heart valve insufficiency are desirable.

SUMMARY

Certain embodiments of the disclosure concern leaflet clips and devicesand methods of introducing leaflet clips into a heart valve. In onerepresentative embodiment, a leaflet clip comprises an elongated memberincluding a proximal end portion and a distal end portion, and first andsecond clipping arms movable between an open position and a closedposition. The clipping arms include respective proximal end portionscoupled to the proximal end portion of the elongated member, andrespective distal end portions extending distally and radially outwardrelative to the elongated member. The leaflet clip further comprises atubular member coaxially disposed about the elongated member. Axialmotion of the tubular member relative to the elongated member or axialmotion of the elongated member relative to the tubular member causescorresponding movement of the clipping arms between the open and closedpositions

In another representative embodiment, a method comprises positioning aleaflet clip adjacent a commissure of a heart valve such that a firstclipping arm is adjacent a first leaflet of the heart valve and a secondclipping arm is adjacent a second leaflet of the heart valve, and anelongated member is positioned between the leaflets. The method furthercomprises moving a sheath disposed coaxially over the elongated memberdistally with respect to the elongated member or moving the elongatedmember proximally with respect to the sheath such that the sheath causesthe clipping arms to move from an open position to a closed position,thereby capturing the first leaflet between the first clipping arm andthe elongated member and capturing the second leaflet between the secondclipping arm and the elongated member.

The foregoing and other objects, features, and advantages of thedisclosure will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a representative embodiment ofa leaflet clip.

FIG. 2 illustrates a partially exploded view of the leaflet clip of FIG.1 with the clipping arms in an open position.

FIG. 3 illustrates a perspective view of the leaflet clip of FIG. 1 withthe clipping arms in a closed position.

FIG. 4 is a perspective view of a representative embodiment of adelivery system that can be used in combination with the leaflet clip ofFIG. 1.

FIG. 5 is an exploded view of the delivery system of FIG. 4.

FIGS. 6 and 7 illustrate an embodiment of an actuator conduit.

FIG. 8 illustrates an embodiment of an outer conduit disposed coaxiallyabout the actuator conduit of FIG. 6.

FIGS. 9 and 10 illustrate an embodiment of a tubular member disposed inthe distal position about an elongated member.

FIG. 11 is a cross-sectional plan view of a heart valve with threeleaflet clips implanted in the heart valve.

FIG. 12 is a schematic illustration of a heart valve illustrating areduction in the diameter of the annulus.

FIG. 13 is a side elevation view of a leaflet clip disposed in a heartvalve with the clipping arms in the open position.

FIG. 14 is a side elevation view of the leaflet clip of FIG. 8 with theclipping arms in the closed position.

FIG. 15 is a schematic plan view of a heart valve illustrating distancesbetween reference points on the walls of the valve annulus.

FIG. 16 is a cross-sectional plan view of a heart valve illustratingdistances between reference points on the walls of the valve annulusprior to implantation of leaflet clips.

FIG. 17 is a cross-sectional plan view of the heart valve of FIG. 11illustrating a reduction in diameter of the valve annulus afterimplantation of leaflet clips.

FIG. 18 is a cross-sectional view of the ventricular side of the aorticvalve illustrating implantation of a support ring on three leafletclips.

FIG. 19 is a cross-sectional view of the aortic side of the valve ofFIG. 13 illustrating a reduction in diameter of the valve annulus withleaflet clips and the support ring.

FIGS. 20 and 21 illustrate implantation of a leaflet clip into a mitralvalve.

FIGS. 22 and 23 illustrate implantation of a leaflet clip into atricuspid valve.

FIGS. 24-32 illustrate various representative configurations of clippingarms of leaflet clips.

FIG. 33 illustrates another embodiment of a leaflet clip including apassive leaflet engaging mechanism.

FIG. 34 illustrates movement of the leaflets of a heart valve withrespect to the clipping arms of a leaflet clip as the clipping arms aremoved from an open position to a closed position.

FIG. 35 is a side elevation view of another embodiment of a leaflet clipincluding a movable and expandable covering illustrated in a distalposition.

FIG. 36 is a side elevation view the leaflet clip of FIG. 26illustrating the active leaflet engaging mechanism in a proximalposition in an expanded configuration.

FIGS. 37 and 38 are side elevation views of another embodiment of aleaflet clip including an active leaflet engaging mechanism including aplurality of protuberances.

FIG. 39 illustrates an embodiment of a leaflet clip coupled to adelivery system with the with the clipping arms of the leaflet clipextending distally relative to the delivery system.

FIG. 40 illustrates an embodiment of a leaflet clip coupled to adelivery system with the clipping arms of the leaflet clip extendingproximally relative to the delivery system.

FIG. 41 illustrates another embodiment of a leaflet clip coupled to adelivery system with its clipping arms extending proximally with respectto the delivery system.

FIGS. 42 and 43 illustrate another embodiment of a leaflet clipincluding tissue gathering regions.

FIGS. 44 and 45 schematically illustrate the function of the tissuegathering regions of the leaflet clip of FIG. 42.

FIG. 46 illustrates the leaflet clip of FIGS. 42 and 43 with theclipping arms in the closed position and leaflets disposed in the tissuegathering regions.

FIG. 47 illustrates another embodiment of a leaflet clip including ahelical member disposed within a tubular central member.

FIG. 48 illustrates another embodiment of a leaflet clip including ahelical member disposed about the clipping arms.

FIG. 49 is a perspective view of another embodiment of a delivery systemthat can be used in combination with any of the leaflet clips describedherein.

FIG. 50 is an enlarged view of the distal end portion of the deliverydevice of FIG. 49.

DETAILED DESCRIPTION

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatuses, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, apparatus, and systems are not limited to anyspecific aspect or feature or combination thereof, nor do the disclosedembodiments require that any one or more specific advantages be presentor problems be solved.

Features, integers, characteristics, compounds, chemical moieties orgroups described in conjunction with a particular aspect, embodiment orexample are to be understood to be applicable to any other aspect,embodiment or example described herein unless incompatible therewith.All of the features disclosed in this specification (including anyaccompanying claims, abstract and drawings), and/or all of the steps ofany method or process so disclosed, may be combined in any combination,except combinations where at least some of such features and/or stepsare mutually exclusive. The invention is not restricted to the detailsof any disclosed embodiments. The invention extends to any novel one, orany novel combination, of the features disclosed in this specification(including any accompanying claims, abstract and drawings), or to anynovel one, or any novel combination, of the steps of any method orprocess so disclosed.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language set forthbelow. For example, operations described sequentially may in some casesbe rearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods.Additionally, the description sometimes uses terms like “provide” or“achieve” to describe the disclosed methods. These terms are high-levelabstractions of the actual operations that are performed. The actualoperations that correspond to these terms may vary depending on theparticular implementation and are readily discernible by one of ordinaryskill in the art.

As used in this application and in the claims, the singular forms “a,”“an,” and “the” include the plural forms unless the context clearlydictates otherwise. Additionally, the term “includes” means “comprises.”Further, the terms “coupled” and “associated” generally meanelectrically, electromagnetically, and/or physically (e.g., mechanicallyor chemically) coupled or linked and does not exclude the presence ofintermediate elements between the coupled or associated items absentspecific contrary language.

As used herein, the term “proximal” refers to a position, direction, orportion of a device that is closer to the user and further away from theimplantation site. As used herein, the term “distal” refers to aposition, direction, or portion of a device that is further away fromthe user and closer to the implantation site. Thus, for example,proximal motion of a device is motion of the device toward the user,while distal motion of the device is motion of the device away from theuser. The terms “longitudinal” and “axial” refer to an axis extending inthe proximal and distal directions, unless otherwise expressly defined.

As used herein, the terms “integrally formed” and “unitary construction”refer to a construction that does not include any welds, fasteners, orother means for securing separately formed pieces of material to eachother.

FIGS. 1-3 illustrate a representative embodiment of a leaflet clip 100including a central elongated member, or shaft, 102, first and secondclipping arms 104, 106, and a tubular member 108 (also referred to as a“cover” or “sheath”) coaxially disposed over the elongated member 102.The elongated member 102 can have a proximal end portion 110 and adistal end portion 112, and can define a lumen 114 (indicated in phantomin FIG. 1) through which a guide wire can be inserted.

The clipping arms 104, 106 can be coupled to the proximal end portion110 of the elongated member, and can be movable between an open position(FIGS. 1 and 2) and a closed position (FIG. 3). In the embodiment shown,the clipping arms 104, 106 extend distally from the proximal end portion110 of the elongated member, and can be shape set such that they curveradially away from the elongated member 102 when in the open position.In some embodiments, the clipping arms 104, 106 can have a curvedcross-sectional profile (in a plane perpendicular to the longitudinalaxis of the elongated member 102) such that they lay substantially flushagainst the elongated member 102 when in the closed position.

As shown in FIG. 2, the clipping arms 104, 106 can extend from anannular collar 116 situated coaxially on the proximal end portion 110 ofthe elongated member 102. In some embodiments, the clipping arms 104,106 can be integrally formed with the collar 116, or can be separatelyformed and attached to the collar 116, as desired. For example, in someembodiments, the clipping arms 104, 106 can be hinged. The annularcollar 116 can also include one or more radially extending protrusionsor tabs 118 extending from the collar 116 and configured to preventrotation of the tubular member 108 (i.e., “index” the tubular member108) with respect to the elongated member 102, as further describedbelow. In some embodiments, the clipping arms 104, 106, and/or thecollar 116, can be made from any biocompatible material such as, forexample, titanium, nickel titanium or nitinol, plastic, stainless steel,etc.

The tubular member 108 can be coaxially disposed over the elongatedmember 102, and can be axially movable with respect to the elongatedmember 102 between a first position (FIG. 1) and a second position (FIG.3), as indicated by arrow 127 of FIG. 1. Referring to FIG. 2, thetubular member 108 can include a proximal end portion 120, and first andsecond extension portions 122, 124 corresponding to the first and secondclipping arms 104, 106. The tubular member 108 can also define slots 126between the extension portions 122, 124, which can receive the tabs 118of the collar 116 when the tubular member 108 is in the second position,as shown in FIG. 3. In this manner, as the tubular member 108 movesdistally from the first position to the second position, the tabs 118can travel in the respective slots 126, and the first and secondextension portions 122, 124 can contact the first and second clippingarms 104, 106, respectively, and urge the clipping arms 104, 106 intothe closed position.

The clipping arms 104, 106 and the elongated member 102 can definerespective leaflet receiving regions configured to receive the leafletsof a heart valve when the clipping arms 104, 106 are in the openposition. For example, the first clipping arm 104 and the elongatedmember 102 can define a first leaflet receiving region 128, and thesecond clipping arm 106 together with the elongated member 102 candefine a second leaflet receiving region 130, as shown in FIGS. 1 and 2.During implantation, the leaflet clip 100 can be positioned adjacent acommissure of a heart valve such that one valve leaflet is received inthe first leaflet receiving region 128 and a corresponding valve leafletis received in the second leaflet receiving region 130, while theelongated member 102 extends between the leaflets. In this manner, whenthe clipping arms 104, 106 are moved from the open position to theclosed position, the leaflets can be captured between the first andsecond clipping arms 104, 106, respectively, and the elongated member102, as further described below.

In some embodiments, the proximal end portion 110 of the elongatedmember 102 can include a locking or retaining feature 132 to retain thetubular member 108 in the second position. In the embodiment shown, theretaining feature 132 can comprise a protuberance 134 located on theproximal end of the elongated member 102. The protuberance 134 can havea diameter greater than a diameter of the tubular member 108 such thatif the proximal end portion 120 of the tubular member 108 is advancedover the protuberance 134, the protuberance 134 will cause the proximalend portion 120 to expand beyond its natural diameter. Once the proximalend portion 120 of the tubular member 108 is advanced distally of theprotuberance 134, the proximal end portion 120 can return to its natural(non-deflected and non-expanded) diameter such that the protuberance 134restrains proximal movement of the tubular member 108 past theprotuberance 134, thereby locking the clipping arms 104, 106 in theclosed position.

In this manner, when the leaflet clip 100 has been positioned at adesired location relative to the leaflets of a heart valve, the tubularmember 108 can be advanced fully to the second position, locking thetubular member 108 distally of the protuberance 134, and thereby lockingthe clipping arms 104, 106 in the closed position such that the leafletclip 100 is retained on the leaflets. In some embodiments, the proximalend portion 120 of the tubular member 108 can define one or more notches136 to allow the walls of the proximal end portion 120 to flare radiallyoutwardly as they pass over the protuberance 134, thereby allowing theproximal end portion 120 to pass more easily over the protuberance 134.The walls of the proximal end portion 120 can then return to theirnatural diameter distally of the protuberance 134.

In some embodiments, the leaflet clip 100 can include active or passiveleaflet engaging mechanisms, which can be disposed on the elongatedmember 102, to aid in engaging and retaining the leaflets of a heartvalve in the respective first and second leaflet receiving regions 128,130 as the clipping arms 104, 106 are moved from the open position tothe closed position. For example, the leaflet clip 100 can include apassive leaflet engaging mechanism configured as a covering 138 disposedon the distal end portion 112 of the elongated member 102. The covering138 can have a textured surface such that it can frictionally engage theleaflets when the leaflets are received in the leaflet receiving regions128, 130, and retain the leaflets in the respective leaflet receivingregions 128, 130 as the clipping arms 104, 106 are moved from the openposition to the closed position. In some embodiments, the covering 138can comprise a woven or braided fabric, or can be a polymeric tube orsleeve configured to be positioned on the distal end portion 112 of theelongated member 102. In some embodiments, the covering 136 can be madeof any of various natural or synthetic materials, such as polyethyleneterephthalate (PET), foam, silicone, or suture material.

FIGS. 4 and 5 illustrate the leaflet clip 100 coupled to arepresentative embodiment of a delivery system 150 that can be used todeliver leaflet clips such as the leaflet clip 100 to a desired heartvalve. The delivery system 150 can comprise a main handle body 152including an outer conduit or shaft 154 movable between a proximalposition and a distal position, control buttons 156, 158, and two gripportions 160. Referring to FIG. 5, the delivery system 150 can furtherinclude an actuator conduit, or shaft, 162 disposed coaxially within theouter conduit 154 and coupled to the tubular member 108, such thatproximal or distal motion of the actuator conduit 162 in the directionsindicated by arrow 164 causes corresponding proximal or distal motion ofthe tubular member 108 with respect to the elongated member 102 and theclipping arms 104, 106.

In some embodiments, the actuator conduit 162 can include a couplingdevice 166 to couple the actuator conduit 162 to the proximal endportion 120 of the tubular member 108, as shown in FIGS. 6-8. In someembodiments, the coupling device 166 can comprise a pair of angled tabs163, 165 coupled to the actuator conduit 162 at their respectiveproximal ends and shape set such that respective angled portions 163A,165A of the tabs 163, 165, extend radially beyond the diameter of theactuator conduit 162, as shown in FIG. 7. In this manner, the tabs 163,165 can act as springs such that when the outer conduit 154 is disposedaround the distal end of the actuator conduit 162 (i.e., in the distalposition), the inner surface of the outer conduit 154 can contact theangled portions 163A, 165A of the tabs 163, 165 and deflect themradially inward with respect to the actuator conduit 162, as shown inFIG. 8. In this manner, the tabs 163, 165 can extend into respectiveopenings defined in the proximal end portion 120 of the tubular member108, such as opening 167 shown in FIGS. 9 and 10. This can allow thetabs 163, 165 of the actuator member 162 to releasably engage thetubular member 108 such that proximal and/or distal motion of theactuator conduit 162 causes proximal and/or distal motion of the tubularmember 108 and, thereby, movement of the clipping arms 104, 106 betweenthe open and closed positions. In alternative embodiments, the actuatorconduit 162 can be coupled to the tubular member 108 by any suitablecoupling mechanism, including, for example, threads, clips, a ball anddetent system, etc.

Proximal motion of the actuator conduit 162 and, thereby, of the tubularmember 108, can be limited by one or more of various controllable motionlimiting mechanisms (e.g., cams, hard stops, pull tabs, etc.) to reducethe risk of locking the tubular member 108 in the distal position priorto successful positioning of the leaflet clip 100 (i.e., to prevent theproximal end portion 120 of the tubular member 108 from moving distallywith respect to the protuberance 134 of the elongated member 102). Themotion limiting mechanism(s) can establish a motion limit stop beyondwhich distal motion of the actuator conduit 162, outer conduit 154, andtubular member 108, as a coupled unit, are restrained relative to theinner shaft 168. In the embodiment shown, such motion limitingmechanisms can be controlled by the control button 156. For example,actuation of the control button 156 can allow the actuator conduit 162,outer conduit 154, and tubular member 108 to be moved past the limitstop such that the proximal end portion 120 of the tubular member 108can move distally over the protuberance 134 of the elongated member 102,thereby locking the clipping arms 104, 106 in the closed position. Thus,after the leaflet clip 100 has been clipped to the leaflets of a heartvalve, the control button 156 can be actuated to allow distal motion ofthe actuator conduit 162, outer conduit 154, and tubular member 108 pastthe limit stop to lock the clipping arms 104, 106 in the closedposition.

Proximal motion of the outer conduit 154 can also be limited by one ormore controllable motion limiting mechanisms to reduce the risk ofaccidental release of the tubular member 108 from the actuator conduit162 during positioning of the leaflet clip 100. In the embodiment shown,such motion limiting mechanisms can be controlled by the control button158. For example, actuation of the control button 158 can allow theouter conduit 154 to be moved proximally with respect to the actuatorconduit 162, thereby uncovering the tabs 163, 165, allowing them toresume their natural non-deflected shape and disengage from the tubularmember 108. This can release the tubular member 108 from the deliverysystem 150. Thus, after final positioning of the leaflet clip 100 in aheart valve, the control button 158 can be actuated to allow proximalmotion of the outer conduit 154 and release of the actuator conduit 162from the tubular member 108.

As for the embodiment shown in FIG. 5, the delivery system 150 canfurther include an inner member, or shaft, 168 disposed coaxially withinthe actuator conduit 162 and coupled at one end to the proximal endportion 110 of the elongated member 102, and at the opposite end to ahandle member 170. In the embodiment shown, the inner member 168 can becoupled to the proximal end portion 110 of the elongated member 102 bythreads such that rotation of the handle member 170 in the directionindicated by arrow 172 can uncouple the inner member 168 from theelongated member 102. For example, the distal end portion of the innermember 168 can have male threads that threadably engage female threadsformed on an inner surface of the proximal end portion 110 of theelongated member 102. In this manner, after final positioning of theleaflet clip 100 in a heart valve, the actuator member 162 can bedisengaged from the tubular member 108, the inner member 168 can bedisengaged from the elongated member 102, and the delivery system 150can be retracted, leaving the leaflet clip 100 in place.

In some embodiments, the diameter of the outer conduit 154 can be aboutten French, and the system 150 can be configured for use with a guidewire (for example, threaded through the lumen 114 of the elongatedmember 102). In some embodiments, the respective conduits 154, 162 andthe inner member 168 of the delivery system 150 can be flexible orrigid, as desired. In some embodiments, the delivery system 150 caninclude steering elements to aid in positioning and orienting theleaflet clip 100 with respect to a heart valve. Also, it should beunderstood that the respective conduits 154, 162 and the inner member168 of the delivery system 150 are shown at reduced length for purposesof illustration, and can be any suitable length.

In use, the delivery system 150 can be introduced into a patient'svasculature (e.g., via the femoral artery or other suitable accesspoint) and percutaneously advanced to the patient's heart with theclipping arms 104, 106 in the closed position (but not locked) using anyof various delivery techniques. In a transfemoral procedure, thedelivery device can be inserted through a femoral artery and the aortato the heart in a retrograde direction (typically, but not exclusivelyused for deploying a clip on the leaflets of the aortic or mitralvalves). Similarly, the delivery device can be inserted through afemoral vein and the vena cava to the right side of the heart in anantegrade direction (typically, but not exclusively used for deploying aclip on the leaflets of the pulmonary or tricuspid valves). In atransventricular procedure, the delivery device can be inserted througha surgical incision made in the chest and on the bare spot on the loweranterior ventricle wall (typically, but not exclusively used fordeploying a clip on the leaflets of the aortic or mitral valves).Similarly, the delivery device can be inserted through a surgicalincision on the wall of the right ventricle to access the pulmonary ortricuspid valves. In a transatrial procedure, the delivery device can beinserted through a surgical incision made in the wall of the left orright atrium to access the native valves on the left or right sides,respectively, of the heart. In a transaortic procedure, the deliverydevice can be inserted through a surgical incision made in the ascendingaorta and advanced toward the heart (typically, but not exclusively useddeploying a clip on the leaflets of the aortic or mitral valves). In atranseptal procedure, the delivery device can be advanced to the rightatrium, such as via a femoral vein, and through the septum separatingthe right and left ventricles (typically, but not exclusively used fordeploying a clip on the leaflets of the aortic or mitral valves).Further details of delivery techniques for accessing the native valvesof the heart are disclosed in U.S. Patent Publication No. 2014/0067052,which is incorporated herein by reference.

Once located proximate the desired heart valve, the clipping arms 104,106 are expanded by retracting the actuator conduit 162 to retract thetubular member 108 relative to the clipping arms 104, 106. The leafletclip 100 can then be positioned with respect to a commissure of thevalve, and can be distally advanced and/or retracted as needed toposition the leaflet clip 100 such that one leaflet of the commissure isreceived in the first leaflet receiving region 128 and the secondleaflet of the commissure is received in the second leaflet receivingregion 130. When the leaflet clip 100 is suitably positioned, theactuator conduit 162 can be advanced such that the tubular member 108moves distally with respect to the elongated member 102 and urges theclipping arms 104, 106 toward the closed position.

When the clipping arms are 104, 106 are in the closed position, theclipping strength of the leaflet clip 100 can be tested by pullingproximally on the delivery system 150. As used herein, the terms “clipretention force” and “clipping strength” refer to a force in theproximal direction that can be withstood by a leaflet clip withoutdisengaging from the leaflets of a heart valve when the clipping armsare in the closed position. In some embodiments, the delivery system 150can include a strain gauge or other device to measure the force appliedto the leaflet clip 100. In some embodiments, the leaflet clip 100 canwithstand a proximal force application of from between 1 N and about 10N while remaining clipped to the valve leaflets. If, for example, theleaflet clip 100 is not suitably positioned, or the leaflet clip 100does not exhibit suitable clipping strength when clipped to theleaflets, the tubular member 108 can be retracted by proximal motion ofthe actuator conduit 162, causing the clipping arms 104, 106 to reopen,and allowing the leaflet clip 100 to be repositioned. When the leafletclip 100 is suitably positioned with respect to the valve leaflets, theactuator member 162 can advance the tubular member 108 distally of theprotuberance 134, thereby locking the clipping arms 104, 106 in theclosed position. The inner member 168 can then be disengaged from theelongated member 102, and the delivery system 150 can be retracted,leaving the leaflet clip 100 in place on the valve leaflets.

The leaflet clip 100, and any of the other leaflet clip embodimentsdescribed herein, can be used to treat valvular insufficiency or toremodel the annulus of a heart valve. For example, FIG. 11 illustratesthree leaflet clips 202, 204, 206 similar to the leaflet clip 100 ofFIG. 1 situated in a native aortic valve 200. The native aortic valve200 can include three valve leaflets 210, 212, 214 attached to a valveannulus 216. The valve leaflets 210 and 212 can form a first commissure218, the leaflets 212 and 214 can form a second commissure 220, and theleaflets 210 and 214 can form a third commissure 222. The leaflet clips202, 204, 206 are shown situated at the first, second, and thirdcommissures 218, 220, 222, respectively, such that the leaflet clip 202engages the leaflets 210 and 212, the leaflet clip 204 engages theleaflets 212 and 214, and the leaflet clip 206 engages the leaflets 214and 210. The leaflet clips 202, 204, 206 are also shown situated nearthe wall of the valve annulus 216. In this manner, the leaflet clips202, 204, 206 can improve coaptation of the leaflets 210, 212, 214 atthe respective commissures 218, 220, 222, thereby reducing regurgitationthrough the valve 200 due to valvular insufficiency. Additionally,although the leaflet clips 202, 204, 206 are shown clipped to therespective valve leaflets adjacent the annulus 216, the leaflet clips202, 204, 206 can be clipped to the valve leaflets at any suitablelocation along the leaflets, including at the centers of thecommissures, as desired.

The leaflet clips 202, 204, 206 can also remodel the annulus 216 of thevalve 200 to reduce dilatation of the annulus 216 and/or to addressabnormalities in the shape of the annulus 216. For example, FIG. 12schematically illustrates remodeling of the annulus 216 to reduce itsdiameter from a dilated annulus diameter D₁ to a target or reducedannulus diameter D₂ using leaflet clips, such as the clips 202, 204,206. Such remodeling or diameter reduction may be achieved by reducingthe circumference of the annulus 216, as illustrated in FIGS. 13 and 14.

For example, FIG. 13 illustrates the leaflet clip 202 with its clip armsin the open position. Hash marks 230, 232 are shown on the tissue forpurposes of indicating an initial distance between the clipping arms, aswell as an initial reference for the circumference of the annulus.Dashed line 234 indicates the native contour of the valve cusp. FIG. 14illustrates the leaflet clip 202 with its clip arms in the closedposition such that the tissue of the annulus 216 adjacent the clip 202is gathered and clipped together by the leaflet clip. This can reducethe circumference and, thereby, the diameter, of the annulus 216, asindicated by movement of the hash marks 230, 232 toward one another.

The effect of such a diameter reduction is further illustrated in FIGS.15, 16, and 17, wherein the distances a, b, and c between three points302, 304, 306 indicated schematically in FIG. 15, and illustrated on theannulus of a heart valve 300 in FIGS. 16 and 17, are reduced afterapplication of three leaflet clips 308, 310, 312 to the commissures ofthe valve 300. In some embodiments, the diameter of the annulus can bereduced from a dilated diameter of about 29 mm to a target diameter ofabout 25 mm. In some embodiments, the diameter of the annulus can bereduced by from about 10% to about 50%. In some embodiments, thediameter of the annulus can be reduced by about 14%.

Any of the leaflet clips disclosed herein can also be used incombination with one or more support rings, as shown in FIGS. 18 and 19.FIG. 19 illustrates three leaflet clips 402, 404, 406 clipped to thecommissures of an aortic valve 400 as seen from the aortic root. FIG. 18illustrates the location of a support ring 408 on the ventricular sideof the aortic valve 400, which can cooperate with the leaflet clips 402,404, 406 to remodel and/or reduce the diameter of the aortic valve 400,as shown in FIG. 19. The extensions 410 of the central shaft of each ofthe leaflet clips within the left ventricle can extend throughrespective openings of the ring 408 as shown. Alternatively, the ring408 can be placed around the extensions 410. The leaflet clips 402, 404,406, together with the support ring 408, or independent of anysupporting device or structure, can also be used to achieve folding orplication of the commissures, as shown in FIG. 19.

As stated above, any of the leaflet clips disclosed herein can also beused to treat valvular insufficiency or to remodel the annulus of themitral valve and/or the tricuspid valve in addition to the aortic valve.FIGS. 20 and 21 illustrate placement of a leaflet clip 502 similar tothe leaflet clip 100 of FIG. 1 onto the leaflets 504, 506 of a mitralvalve 500. As illustrated in FIGS. 20 and 21, the relatively small widthof the clip arms 508 of the leaflet clip 500 relative to the chordae ofthe mitral valve 500 can reduce interference by the clip arms 508 withthe chordae both during implantation of the leaflet clip 502 and afterimplantation. In use, one or more leaflet clips 502 can be placed at ornear the center of the leaflets 504, 506, or near the annulus, asdesired.

FIGS. 22 and 23 illustrate placement of a leaflet clip 602 similar tothe leaflet clip 100 of FIG. 1 onto leaflets 604, 606 of a tricuspidvalve 600. The leaflet clip 602, alone, or in combination with one ormore additional leaflet clips, can be used to reduce valvularinsufficiency and/or remodel the valve annulus, as described above.

FIGS. 24-32 illustrate various configurations of clipping arms that maybe used in combination with any of the leaflet clips disclosed herein.Additionally, although the leaflet clips of FIGS. 24-26 are illustratedwithout central elongated members, it should be understood that any ofthe leaflet clips described herein can include an elongated member(e.g., member 102) or not, as desired. FIG. 24 illustrates a leafletclip 700 wherein the clipping arms 702, 704 exhibit bends indicated at702A and 704A, and extend outwardly without exhibiting any significantfurther curvature (i.e., the clipping arms 702, 704 are relativelystraight).

FIG. 25 illustrates a leaflet clip 800 wherein the clipping arms 802,804 exhibit two bends, the first bends being indicated at 802A, 804A,and the second bends indicated at 802B, 804B, respectively, such thatthe clipping arms 802, 804 include respective distal portions 806, 808angled away from the tubular member 810 at an angle a greater than about45 degrees.

FIG. 26 illustrates a leaflet clip 900 wherein the clipping arms 902,904 have curved distal end portions 906, 908.

FIG. 27 illustrates a leaflet clip 1000 similar to the leaflet clip 800of FIG. 25 wherein the clipping arms 1002, 1004 exhibit first bendsindicated at 1002A, 1004A and second bends indicated at 1002B, 1004Bsuch that distal portions 1006, 1008 of the clipping arms 1002, 1004 areangled away from the tubular member 1010 at an angle a less than about45 degrees.

FIG. 28 illustrates a leaflet clip 1100 wherein the clipping arms 1102,1104 extend distally adjacent the elongated member 1106 before bendingaway from the elongated member 1106 such that the areas of therespective leaflet receiving regions 1108, 1110 are reduced.

FIGS. 29 and 30 illustrate an embodiment of a clipping arm 1600including one or more openings 1602 defined in the clipping arm 1600.The clipping arm 1600 can include openings 1602 located at the distalend portion of the clipping arm 1600, as shown in FIG. 29, or spacedapart along the length of the clipping arm 1600, as shown in FIG. 30.The clipping arm 1600 can include a fibrous covering or sleeve 1604,which can be disposed around the distal end portion of the clipping arm1600, as in FIG. 29, or along the entire length of the clipping arm1600, as shown in FIG. 30. The covering 1604 can be retained on theclipping arm 1600 by suture threads 1606, which can be disposed aboutthe covering 1604 and received or laced through the plurality ofopenings 1602 in order to retain the covering 1604 on the clipping arm1600. In this manner, the covering 1604 can serve to frictionally engagethe tissue of the leaflets of a heart valve while reducing the risk ofdamage to the leaflets. In alternative embodiments, the clipping arm1600 can include any suitable number of openings 1602 located at anysuitable location along the length of the clipping arm, and can includea covering extending along any suitable proportion of the clipping arm1600, as desired. The covering 1604 can be made from a suitablebiocompatible fabric, such as PET.

FIG. 31 illustrates another embodiment of a clipping arm 1700 includinga proximal end portion 1702 and a distal end portion 1704. In theembodiment shown, clipping arm 1700 can be tapered such that theproximal end portion 1702 has a first diameter or width W₁ and thedistal end portion 1704 has a second diameter or width W₂, the firstdiameter W₁ being greater than the second diameter W₂. This can allowthe distal end portion 1704 a greater degree of flexibility relative tothe proximal end portion 1702 in the directions indicated by arrow 1706,which can reduce the risk of damage to the tissue of native heart valveleaflets. The distal end portion 1704 can also include a protuberance1708 having a relatively large diameter relative to the diameter W₂ ofthe distal end portion 1704, which can reduce the risk of puncturing thenative leaflets during or after implantation of the leaflet clip.

FIG. 32 illustrates another embodiment of a clipping arm 1800 includingan inner member 1802 and an over-molded covering 1804 (i.e., an “insertmolding”). The covering 1804 can be fabricated from any biocompatiblepolymer (e.g., silicone, ePTFE, etc.), and can include texturing,dimpling, or other surface features to aid in engaging and retaining thetissue of a native valve leaflet. The inner member 1802 can befabricated from metal or polymer materials, as desired.

FIG. 33 illustrates another embodiment of a leaflet clip 1200 similar tothe leaflet clip 100 of FIG. 1. The leaflet clip 1200 can include anelongated member 1202 and two clipping arms 1204, 1206. The leaflet clip1200 is illustrated without a tubular member (sheath) for purposes ofillustration. The leaflet clip 1200 can include a passive leafletengaging mechanism configured as a tube or sleeve 1208 and disposed on adistal end portion 1210 of the elongated member 1202. The sleeve 1208can be made from, for example, polyester, and can be configured tofrictionally engage and retain the leaflets of a heart valve between therespective clipping arms 1204, 1206 and the elongated member 1202 as theclipping arms are moved from the open position to the closed position.

FIG. 34 schematically illustrates the relative positions of the nativeleaflets 1302, 1304 of a heart valve 1306 relative to the clipping arms1308, 1310 of a leaflet clip 1300 before and after the clipping arms1308, 1310 are moved from the open position to the closed position. In amanner similar to leaflet clip embodiments described above, distalmotion of a tubular member 1316 from a first position (indicated insolid lines) to a second position (indicated in phantom) can cause theclipping arms 1308, 1310 to move from the open position to the closedposition. When the leaflets 1302, 1304 are received in the respectiveleaflet receiving regions 1312, 1314, the ends of the clipping arms1308, 1310 can contact the leaflets 1302, 1304 at respective points Aalong the respective leaflets 1302, 1304. In some embodiments, as theclipping arms 1308, 1310 are moved from the open position to the closedposition, the leaflets 1302, 1304 can slip such that when the clippingarms 1308, 1310 are in the closed position, they contact the leaflets1302, 1304 at respective points B. Depending upon the degree of grippingstrength desired, it may be advantageous, in certain circumstances, toretain a greater proportion of the leaflets 1302, 1304 in the leafletreceiving regions 1312, 1314 as the clipping arms are moved from theopen position to the closed position.

To such ends, FIGS. 35 and 36 illustrate another embodiment of a leafletclip 1400 including an elongated member 1402 and two clipping arms 1404,1406. The leaflet clip 1400 can include an active leaflet engagingmechanism 1408 configured as a woven or braided covering 1410 disposedon the elongated member 1402 between a stationary proximal retainingmember 1412 and a distal retaining member 1414 movable between a distalposition and a proximal position. When the leaflet clip 1400 ispositioned such that native leaflets 1416, 1418 are received in therespective leaflet receiving regions 1420, 1422, the distal retainingmember 1414 can be moved proximally in the direction indicated by arrow1424 of FIG. 36 (e.g., by actuation of a member disposed within theelongated member 1402). Motion of the distal retaining member 1414toward the proximal retaining member 1412 can cause the covering 1410 tobunch such that it expands or bulges radially away from the elongatedmember 1402 and engages the leaflets 1416, 1418 between the covering1410 and the respective clipping arms 1404, 1406. When the distalretaining member 1414 is in the proximal position, the tubular member1426 can be advanced distally such that the clipping arms 1404, 1406 aremoved from the open position to the closed position. In this manner,retention of the leaflets 1416, 1418 in the respective leaflet receivingregions 1420, 1422 while the clipping arms 1404, 1406 are moved to theclosed position can result in a greater proportion of the leaflets beingretained against the elongated member 1402 by the leaflet clip 1400,resulting in a stronger grip on the leaflets and improved performance ofthe leaflet clip 1400. Additionally, the leaflet engaging mechanism 1408can reduce slippage of the leaflets 1416, 1418 past the clipping arms1404, 1406 as they moved to the closed position, helping to ensure thata greater proportion of the leaflets 1416, 1418 are retained in theleaflet receiving regions 1420, 1422 and increasing retention of theleaflet clip 1400 on the leaflets 1416, 1418.

FIGS. 37 and 38 illustrate another embodiment of a leaflet clip 1500including an elongated member 1502, two clipping arms 1504, 1506, and asheath 1526. The leaflet clip 1500 can include an active leafletengaging mechanism 1508 configured as a sleeve 1510 including aplurality of protuberances 1512 axially spaced apart from one anotheralong the sleeve 1510. The sleeve 1510 can be movable between a distalposition and a proximal position relative to the clipping arms 1504,1506, as indicated by arrow 1514 (FIG. 37). The protuberances 1512 canhave respective edge portions 1516 configured to engage or grip nativeleaflets 1518, 1520 disposed in respective leaflet receiving regions1522, 1524 when the sleeve 1510 is moved proximally, as depicted in FIG.38. Thus, when the clipping arms 1504, 1506 are moved to the closedposition (e.g., by advancing the sheath 1526 over the clipping arms),the edge portions 1516 of the protuberances 1512 can engage and retainthe leaflets 1518, 1520 within the leaflet receiving regions 1522, 1524,thereby inhibiting the leaflets from slipping out of the leafletreceiving regions. This can result in a greater proportion of theleaflets 1518, 1520 being retained against the elongated member 1502 bythe clipping arms 1504, 1506, resulting in a stronger grip on theleaflets and improved performance of the leaflet clip 1500.

In the embodiment shown, the sleeve 1510 includes three protuberances1512. However, it should be understood that the sleeve 1510 can includeany suitable number of protuberances having any suitable size andspacing relative to one another. In some embodiments, the sleeve 1510can be disposed on the elongated member 1502, which can be movableproximally and/or distally. In alternative embodiments, the sleeve 1510can be disposed on a shaft or conduit coaxially disposed within (or overthe exterior) of the elongated member 1502 and independently actuatedfrom outside the body. In some embodiments, the sleeve 1510 can be madefrom suitable natural or synthetic material, such as, for example,polyester. In some embodiments, the spaces between the protuberances1512 can act as tissue gathering regions (see description regardingFIGS. 42-46), helping to increase the clipping strength of the leafletclip 1500.

FIGS. 39 and 40 schematically illustrate alternative couplingorientations of leaflet clips with respect to delivery systems. In FIG.39, a leaflet clip 1900 is shown coupled to a delivery system 1902 withclipping arms 1904, 1906 extending distally with respect to the deliverysystem 1902. FIG. 40 illustrates a leaflet clip 2000 coupled to adelivery system 2002 with the clipping arms 2004, 2006 extendingproximally with respect to the delivery system 2002. It should beunderstood that these coupling orientations may be applied to any of theleaflet clips described herein, and can facilitate the various deliverytechniques described above.

FIG. 41 illustrates another embodiment of a leaflet clip 2100 coupled toa delivery system 2102 such that clipping arms 2104, 2106 extendproximally with respect to the delivery system 2102, similar to theembodiment of FIG. 40. The leaflet clip 2100 can include a tubularmember 2108 disposed coaxially about an elongated member 2110, andmovable between a distal position and a proximal position such that theclipping arms 2104, 2106 are urged by the tubular member 2108 from anopen position to a closed position, respectively. The tubular member2108 can be coupled to an actuator member 2112 via a coupling device2114, illustrated as a threaded connection between the distal end of thetubular member 2108 and the actuator member 2112. The actuator member2112 can extend coaxially through the elongated member 2110, and can bemovable with respect to the elongated member 2110 in the directionindicated by arrow 2113 such that proximal or distal motion of theactuator member 2112 causes corresponding proximal or distal motion ofthe tubular member 2108.

The elongated member 2110 can be coupled to an inner conduit 2116 bytabs 2118, 2120 received in respective openings 2122, 2124 of theelongated member 2110. The tabs 2118, 2120 can be retained in theopenings 2122, 2124 by an adjacent outer conduit 2126 coaxially disposedabout the inner conduit 2116 and configured such that an inner surfaceof the outer conduit 2126 contacts and urges or deflects the tabs 2118,2120 into the openings 2122, 2124 of the elongated member 2110. In thismanner, the leaflet clip 2100 can remain coupled to the delivery system2102 while allowing proximal and distal motion of the actuator member2112 and the tubular member 2108 to facilitate positioning and/orrepositioning of the clipping arms 2104, 2106.

In the embodiment shown, the elongated member 2110 can include tabs orextension portions 2128, 2130 near the distal end of the elongatedmember 2110, which can be received in corresponding openings 2132, 2134defined in the tubular member 2108. In this manner, after finalpositioning of the leaflet clip, the actuator member 2112 can be movedproximally with respect to the elongated member 2110 such that tubularmember 2108 deflects the clipping arms 2104, 2106 into the closedposition and the tabs 2128, 2130 are received in the openings 2132, 2134of the tubular member 2108, thereby locking the tubular member 2108 inthe proximal position and, thereby, locking the clipping arms 2104, 2106in the closed position. The outer conduit 2126 can then be movedproximally in the direction of arrow 2136, allowing the tabs 2118, 2120of the inner conduit 2116 to disengage from the elongated member 2110.The actuator member 2112 can then be rotated, for example, in thedirection indicated by arrow 2138 such that the threaded coupling 2114between the actuator member 2112 and the tubular member 2108 isdisengaged. The delivery system 2102 may then be withdrawn, leaving theleaflet clip 2100 in place.

FIGS. 42 and 43 illustrate another embodiment of a leaflet clip 2200including an elongated member 2202, first and second clipping arms 2204,2206, and a tubular member 2208 disposed coaxially with respect to theelongated member 2202. The elongated member 2202 can have a proximal endportion 2210 and a distal end portion 2212, with the distal end portion2212 having a diameter D₁ that is greater than a diameter D₂ of theproximal end portion 2210. In this manner, the clipping arms 2204, 2206can define respective tissue gathering regions 2214, 2215 between therespective clipping arms 2204, 2206 and the elongated member 2202 whenthe clipping arms are in the closed position, as shown in FIG. 43. Inthe embodiment shown, the tissue gathering regions 2214, 2215 can haverespective width dimensions X₁ and X₂, and height dimensions H₁ and H₂.In some embodiments, the width dimensions X₁ and X₂ can vary along theheight of the respective tissue gathering regions due to, for example,the angle between the respective clipping arms 2204, 2206 and theelongated member 2202, and/or flexion in the clipping arms 2204, 2206when they are in the closed position.

The clipping arms 2204, 2206 can also define respective tissuecompression regions 2220, 2222 between the clipping arms 2204, 2206 andthe elongated member 2202 having respective width dimensions W₁ and W₂.In some embodiments, the dimensions W₁ and W₂ can vary along the lengthof the respective tissue compression regions 2220, 2222 due to the anglebetween the respective clipping arms 2204, 2206 and the elongated member2202, and/or flexion in the clipping arms 2204, 2206, as describedabove.

The tissue gathering regions 2214, 2215 can be located adjacent theproximal end portion of the elongated member 2202, and can be configuredsuch that the end portions of the native leaflets of a heart valveextend into the tissue gathering regions 2214, 2215. In the tissuegathering regions 2214, 2215, the tissue of the free end portions of theleaflets can gather or bunch, while the lower portions of the leafletscan be simultaneously engaged or pinched between the clipping arms 2204,2206 and the elongated member 2202 in the tissue compression regions2220, 2222. This can result in a difference between the thickness of theleaflet tissue in the tissue gathering regions 2214, 2215, where thetissue is relatively unconfined and/or not compressed, and the thicknessof the leaflet tissue disposed in the tissue compression regions 2220,2222. This difference in thickness can significantly increase theclipping strength of the leaflet clip 2200, thereby increasing theleaflet clip's ability to remain clipped to the leaflets of a workingheart valve.

For example, FIGS. 44 and 45 schematically illustrate the mechanics ofthe tissue gathering regions and the tissue compression regions. In FIG.44, the free end portion 2304 of a leaflet 2302 is pinched between aclipping arm 2306 and an elongated member 2308 of a leaflet clip 2300.In an unconstrained state, the leaflet 2302 can have a thickness T, andthe leaflet clip 2300 can be configured such that the clipping arm 2306and the elongated member 2308 define a tissue compression region 2310(corresponding to the tissue compression regions 2220, 2222 of FIGS. 42and 43) having a dimension D when the clipping arm 2306 is in the closedposition. In a typical example, the distance D between the elongatedmember 2308 and the clipping arm 2306 can be configured to compress thetissue of the leaflet 2302 such that the thickness T of the leaflettissue is reduced by about 50% relative to the thickness of theunconstrained tissue. Thus, for a valve leaflet having a thickness T ofabout 1 mm, the tissue compression region 2310 can be configured tocompress the tissue disposed in the region 2310 such that its thicknessT is reduced to about 0.5 mm. This ratio of thickness reduction cangenerally result in greater retention of the leaflet tissue between theclipping arm 2306 and the elongated member 2308, while minimizing therisk of damage to the leaflet 2302.

As stated above, FIG. 44 illustrates the free end portion 2304 of theleaflet 2302 disposed in the tissue gathering region 2310. In a typicalexample, such an arrangement can withstand a proximal force applicationof approximately 1 N. However, by configuring the leaflet clip 2300 suchthat the free end portion 2304 of the leaflet 2302 is relativelyunconstrained, such as when disposed in a tissue gathering region, whilea mid-portion 2312 of the leaflet 2302 is compressed in the tissuecompression region 2310, the clipping strength of the leaflet clip canbe significantly increased. FIG. 45 schematically illustrates such anarrangement, wherein the mid-portion 2312 of the leaflet 2302 is pinchedin the leaflet compression region 2310 such that its thickness isreduced to about 0.5 T, while the free end portion 2304 of the leaflet2302 is disposed in a tissue gathering region 2314 and allowed tomaintain its natural thickness T. In some embodiments, this arrangementcan allow the leaflet clip 2300 to withstand a proximal forceapplication of about 4 N, which can significantly improve the clippingstrength of the leaflet clip. Use of features such as the tissuegathering regions 2214, 2215 can also promote long-term stability of theleaflet clip 2200 after implantation by fostering tissue growth intissue gathering regions 2214, 2215 and around the clip 2200.

Returning to the leaflet clip 2200, FIG. 46 illustrates the leaflet clip2200 with the clipping arms 2204, 2206 in the closed position withleaflets 2216, 2218 captured in the tissue compression regions 2220,2222. The tissue compression regions 2220, 2222 can be configured suchthat the portions of the leaflets 2216, 2218 disposed in the regions2220, 2222 can be compressed such that their respective thicknesses Tare reduced to about 0.5 T, as described above. Meanwhile, the tissuegathering regions 2214, 2215 can be configured such that the free endportions 2224, 2226 of the leaflets 2216, 2218 are allowed to maintainto their natural thickness T, which can significantly increase theclipping strength of the leaflet clip 2200.

In some embodiments, the width dimensions X₁, X₂ and the heightdimensions H₁, H₂ of the tissue gathering regions 2214, 2215, and/or thewidth dimensions W₁, W₂ of the tissue compression regions 2220, 2222 canbe sized according to the thickness T of the valve leaflets 2218, 2220.For example, in some embodiments, the width dimensions X₁, X₂ of thetissue gathering regions 2214, 2215 can be from about 1 T to about 2 T.In some embodiments, the width dimensions X₁, X₂ of the tissue gatheringregions 2214, 2215 can be about 1 T. In some embodiments, the heightdimensions H₁, H₂ of the tissue gathering regions 2214, 2215 can be fromabout 1 T to about 2 T. In some embodiments, the width dimensions W₁, W₂of the tissue compression regions 2220, 2222 can be about 0.5 T, asdescribed above.

FIG. 47 illustrates another embodiment of a leaflet clip 2400 includinga tubular central member 2402 having a proximal end portion 2404 and adistal end portion 2406. The distal end portion 2406 can include firstand second clipping arms 2408, 2410 movable between an open position anda closed position. The clipping arms 2408, 2410 can define a leafletreceiving region 2411 therebetween, which can receive leaflets 2416,2418 of a heart valve. The leaflet clip 2400 can also include a tubularexterior member 2412 disposed coaxially about the central member 2402and movable between a proximal position and a distal position relativeto the central member 2402. The exterior member 2412 can be configuredsuch that as it is moved from the proximal position to the distalposition, an interior surface of the exterior member 2412 contacts theclipping arms 2408, 2410 and urges or deflects them from the openposition to the closed position.

The leaflet clip 2400 can also include a helical member 2414,illustrated in the shape of a corkscrew. The helical member 2414 can bedisposed within the lumen of the central member 2402, and can be movablebetween a proximal position and distal position relative to the centralmember 2402. In this manner, when the leaflets 2416, 2418 are receivedin the leaflet receiving region 2411 and the clipping arms 2408, 2410are in the closed position, the helical member 2414 can be advanceddistally through the lumen of the central member 2402 to engage theleaflets 2416, 2418. This can result in plication of the leaflets 2416,2418, and improve the clipping strength of the leaflet clip 2400. Insome embodiments, the helical member 2414 can pierce the leaflets 2416,2418, or can engage the leaflets 2416, 2418 without piercing them, asdesired. In some embodiments, the helical member 2414 can also include adetachable coupling mechanism 2420 for coupling the leaflet clip 2400 toa delivery device.

FIG. 48 illustrates another embodiment of a leaflet clip 2500 includinga central member 2502 with two clipping arms 2504, 2506 extendingdistally therefrom. The clipping arms 2504, 2506 can be movable betweenan open position and a closed position, and can define a leafletreceiving area 2508, which can receive leaflets 2510, 2512. The leafletclip 2500 can further include a helical member 2514, which can bemovable between a proximal position and a distal position. In someembodiments, the helical member 2514 can comprise, for example, aspirally wound metal wire. When the helical member 2514 is in the distalposition, it can be disposed around the clipping arms 2510, 2512 andconfigured to restrain radial movement of the clipping arms 2504, 2506with respect to one another. In this manner, the helical member 2514 canretain the leaflets 2510, 2512 between the clipping arms 2504, 2506,thereby retaining the leaflet clip 2500 on the heart valve.

FIGS. 49 and 50 illustrate another embodiment of a delivery device 2600that can be used in combination with any of the leaflet clips describedherein. The delivery device can include a handle body 2602 including aproximal handle portion 2604 and a distal handle portion 2606. Thedelivery device can further comprise an outer conduit 2608 coupled tothe distal handle portion 2606, and an intermediate or clip releaseconduit 2610 disposed coaxially within the outer conduit 2608 andcoupled to the proximal handle portion 2604. The clip release conduit2610 can be movable proximally and distally relative to the outerconduit 2608 with proximal and distal motion of the proximal handleportion 2604. The delivery device can further include a clip retentionconduit 2612 disposed coaxially within the clip release conduit 2610 andcoupled to the distal handle portion 2606. In the illustratedembodiment, the clip retention conduit 2612 can include tab portions2614, 2616 (FIG. 50) that engage openings in a tubular member 2618 ofthe leaflet clip 2620 when covered and deflected inwardly by the cliprelease conduit 2610, similar to the embodiment of FIGS. 1-10 above.

The delivery device can also include an inner shaft or conduit 2622(FIG. 40) disposed coaxially within the clip retention conduit 2612. Theinner shaft 2622 can be coupled to a proximal end portion of the centralelongated member 2624 (FIG. 50) of the leaflet clip such that proximaland distal motion of the inner shaft 2622 causes corresponding proximaland distal motion of the elongated member 2624 relative to the tubularmember 2618. By moving the central elongated member 2624 of the leafletclip relative to the tubular member 2618, the clip arms 2626, 2628 canbe drawn proximally into the tubular member 2618 and deflected such thatthe clip arms are moved to the closed position, or pushed distally fromthe tubular member such that the clip arms return to theirnon-deflected, open state. Alternatively, the inner shaft 2622 can becoupled to the tubular member 2618 such that longitudinal motion of theinner shaft causes corresponding longitudinal motion of the tubularmember to open and close the clip arms.

In the illustrated embodiment, the inner shaft 2622 can also include ahandle portion 2630 for effecting proximal and distal motion of theinner shaft. The inner shaft 2622 can also define a lumen that is incommunication with a lumen of the elongated member 2624 for receiving aguide wire. The handle portion 2602 can also include a locking featureto prevent inadvertent separation of the proximal and distal handleportions (e.g., during shipment).

In the illustrated embodiment, the clip release conduit 2610 can includea pin or projection 2632 movable with the clip release conduit in atrack or guide 2634 defined in the outer conduit 2608. In theillustrated embodiment, the guide 2634 can include a circumferentiallyextending distal portion 2636, a longitudinally extending intermediateportion 2638, and a longitudinally extending proximal portion 2640circumferentially offset from the intermediate portion, although otherconfigurations are possible.

When the device is inserted into the body and advanced toward the heart,the proximal and distal handle portions 2604, 2606 can be adjacent oneanother, and the clip release conduit 2610 can be distally disposed suchthat the projection 2632 is in the distal portion 2636 of the guide 2634and the leaflet clip is located within the lumen of the clip releaseconduit. When the distal end of the device reaches the desiredimplantation site, the proximal handle portion 2604 can be rotated,causing corresponding rotation of the clip release conduit 2610. Thiscan cause the projection 2632 of the clip release conduit to move intothe intermediate portion 2638 of the guide 2634. The proximal handleportion 2604 can then be pulled proximally or retracted such that theproximal handle portion separates from the distal handle portion 2606,causing corresponding proximal movement of the clip release conduit 2610and of the projection 2632 in the intermediate portion 2638 of theguide. The clip release conduit 2610 can be retracted a sufficientdistance to expose the clip arms of the leaflet clip 2620, but not sofar that the tabs 2614, 2616 of the clip retention conduit are exposedand allowed to open and release the leaflet clip from the deliverydevice.

The leaflet clip 2620 can then be clipped onto and/or released from thenative leaflets of the target heart valve by proximal and distal motionof the inner shaft 2622. When a suitable placement of the leaflet clipon the native leaflets has been achieved, the clip arms 2626, 2628 canbe locked in the closed position. The proximal handle portion 2604 canthen be rotated such that the projection 2632 moves into the distalportion 2640 of the guide 2634. This allows the handle portion 2604 tobe moved further in the proximal direction such that the clip releaseconduit 2610 uncovers the tabs 2614, 2616 of the clip retention conduit2612, releasing the leaflet clip from the delivery device.

The delivery device illustrated in FIGS. 49 and 50 can be adapted foruse with a transapical delivery procedure. However, it should beunderstood that the device of FIGS. 49 and 50 can be adapted for usewith any suitable delivery procedure, including transfemoral procedures,transatrial procedures, transeptal procedures, etc.

In view of the many possible embodiments to which the principles of thedisclosed technology may be applied, it should be recognized that theillustrated embodiments are only preferred examples and should not betaken as limiting the scope of the disclosure. Rather, the scope of thedisclosure is defined by the following claims.

We claim:
 1. A clip for attachment to two leaflets of a heart valvecomprising: an elongated member configured to be positioned between thetwo leaflets of the heart valve; wherein the elongated member has afirst portion and a second portion that extends from the first portion;wherein a width of the second portion is greater than the width of thefirst portion; a pair of arms that are coupled to the first portion andextend toward the second portion; wherein the pair of arms extendradially away from the elongated member as the pair of arms extend awayfrom the first portion toward the second portion when the arms are in anopen position; and wherein the pair of arms are moveable from the openposition to a closed position to pinch each of the leaflets between oneof the arms and the elongated member.
 2. The clip of claim 1 furthercomprising a tubular member configured to move the pair of arms from theopen position to the closed position.
 3. The clip of claim 1 wherein aleaflet tissue gathering space is defined between each of the arms andfirst portion of the elongated member when the arms are in the closedposition.
 4. The clip of claim 3 wherein the pair of arms and the secondportion of the elongated member are configured to compress the leaflettissue when the arms are in the closed position.
 5. A valve repairsystem comprising: a clip for attachment to two leaflets of a heartvalve comprising: an elongated member configured to be positionedbetween the two leaflets of the heart valve; a pair of arms that arecoupled to a first end portion of the elongated member; wherein the pairof arms extend radially away from the elongated member as the pair ofarms extend away from the first end portion toward a second end portionwhen the arms are in an open position; a delivery system comprising: anactuator member that extends into the second end portion of theelongated member and through the elongated member such that a distal endof the actuator is past the second end portion of the elongated member;a conduit releasably coupled to the second end portion of the elongatedmember; wherein movement of the distal end of the actuator member towardthe conduit moves the pair of arms from an open position to a closedposition.
 6. The system of claim 5 further comprising a tubular memberconnected to the distal end of the actuator member and configured tomove the pair of arms from the open position to the closed position. 7.The system of claim 5 wherein the end of the distal end of the actuatormember is threaded.
 8. The system of claim 5 wherein the distal end ofthe actuator member is threaded into a component of the clip to attachthe clip to the actuator member.
 9. The system of claim 5 wherein theconduit is coupled to the second end portion of the elongated member bytabs that are deflected radially inward.
 10. The system of claim 9wherein the conduit is released from the elongated member by releasingthe tabs to allow the tabs to move radially outward.
 11. The system ofclaim 5 wherein the end of the actuator member is threaded into acomponent of the clip to attach the clip to the actuator member and theconduit is coupled to the second end portion of the elongated member bytabs that are deflected radially inward.
 12. The system of claim 11wherein the clip is released from the delivery system by unthreading theactuator member from the component of the clip and by releasing the tabsto allow the tabs to move radially outward.
 13. The system of claim 11wherein the component of the clip includes an annular threaded end. 14.The system of claim 11 wherein the component of the clip comprises atubular member.
 15. The system of claim 5 wherein the width of thesecond portion of the elongated member is greater than the width of thefirst portion of the elongated member.
 16. A clip for attachment to twoleaflets of a heart valve comprising: an elongated member configured tobe positioned between the two leaflets of the heart valve; an expandablecovering disposed over the elongated member; wherein the expandablecovering is configured to expand radially away from the elongatedmember; a pair of arms that are coupled to a first end portion of theelongated member; wherein the pair of arms extend radially away from theelongated member as the pair of arms extend away from the first endportion toward a second end portion when the arms are in an openposition; wherein the pair of arms are moveable from the open positionto a closed position.
 17. The clip of claim 16 wherein the expandablecovering is made from a woven or braided material.
 18. The clip of claim16 wherein the expandable material is disposed between a proximalretaining member and a distal retaining member.
 19. The clip of claim 18wherein the distal retaining member is moveable toward the proximalretaining member to radially expand the expandable covering.
 20. Theclip of claim 16 further comprising a tubular member configured to movethe pair of arms from the open position to the closed position.